Hazards of self-medication and urgent need for regulation

Advocate Satya Muley, practising at Bombay High Court, sheds light on the problems caused due to self-medication and the rise in OTC drugs market, while also explaining the need for regulating such drugs

Perhaps more than any industry in the country, Indian healthcare sector has undergone major transformation since the COVID-19 pandemic.

From using sanitisers, facial masks to using digital technology to help people manage their health, pandemic has changed nearly everything about the healthcare system.

However, even before the pandemic, one segment in the Indian healthcare market had already experienced a huge surge— the ‘OTC drug market.’

Self-medication has become quite common, especially in a country like India. Medicines for cough, cold, flu drugs, dermatology products, gastro-intestinal products, vitamins, minerals, supplements (VMS) etc., are now being sold more like consumer goods.

It seems that the pandemic has further accelerated its growth. The revenue from the Indian OTC market in 2021 was approximately $7.62 billion. But, it is predicted that the market will grow at a CAGR of 9.2 per cent over the forecast period of 2021-2026.

Use of OTC drugs means either the Indian healthcare system has successfully equipped people with knowledge and access to appropriate healthcare products; or it is under a serious crisis because of this growing preference for self-medication based on half-baked knowledge.

Why is the OTC drug market growing rapidly?

Reports by the International Journal of Community Medicine and Public Health in 2018 and Current Clinical Pharmacology in November 2019 have identified several reasons for the growth in the OTC segment.

Some of the major factors for opting OTC drugs include income, occupation and education. Interestingly, this trend was observed in urban areas as well. Familiarity with the medication and being from middle-lower class families are also some of the key causal elements in increasing the likelihood of consuming medicines without a prescription.

The pandemic has only added to the self-medication tendencies. Be it the immunity-boosting solutions like Baba Ramdev’s ‘Coronil’ or the homeopathic medicines like arsenic album —an increase in consumer attitude towards self-medication and product innovation are the primary causes of the OTC market growth in India.

Accordingly, pharmaceutical giants like Emami, Dabur India, Procter and Gamble, Abbott Laboratories and GlaxoSmithKline PLC, who currently dominate the OTC drug market, are now focussing on new product developments and acquisition strategies.

Digitisation in urban areas has enabled providers like Tata 1mg, Pharmeasy, Netmeds, Apollo Pharmacy and others to deliver OTC drugs at the doorsteps of consumers, implying that there is an ease in access to healthcare. On the contrary, COVID-19 forced the rural citizens to self-medicate— due to lack of availability of other medical services, implying a lack of access to healthcare.

Need for regulation

In India, unlike prescription drugs, OTC drugs are not defined as a distinct category of drugs under any legislation.

The Drugs Consultative Committee (DCC) set up by the Central Government under Section 7 of the Drugs and Cosmetic Act, 1940 has been in the process of contemplating specific rules and regulations to govern OTC drugs since 2017. However, not much progress has been made so far.

Meanwhile, the lack of adequate regulations on OTC drugs has been a significant concern that urgently needs attention of the Indian regulators.

The lack of adequate knowledge about the ailment and its medication is the primary hazard to the health of the patients opting for self-medication. In India, minor ailments like headache, fever, body pain and cough are normatively treated by self-medication. However, the consumers are usually unaware of the possible potential serious diseases, adverse reactions, contraindications, and the therapeutic value of these drugs.

A regulation of OTC drugs can instruct the manufacturers to provide adequate labelling on these drugs which is consumer-friendly and is in a sufficiently legible font. The suggestions for OTC medicines by the Indian Pharmaceutical Drugs Association in 2018 also illustrate a possible way to achieve this by including PPI (Patient Product Information) or a PIL (Patient Information Leaflet) in at least two languages. Adequate regulations in the use of electronic media for advertising can also be helpful in educating the consumers, if regulated sufficiently.

Another possible hazard of a thriving but unregulated OTC market can be the misuse or dependence on drugs like sedatives, analgesics, antacids and laxatives.

A delayed diagnosis of serious underlying conditions that require professional medical attention also poses a formidable challenge for patients who opt to consume OTC medication. The profoundly low doctor-to-patient ratio in the country further complicates this situation.

What should India do?

India should learn from Canada’s “First Do No Harm” programme of 2013 against OTC drug abuse that provided a creative solution to this problem. Prescription monitoring programmes to collect, monitor, and analyse electronically transmitted prescribing and giving pharmacists real-time information about potential OTC drug abuse at the time of purchase are possible solutions to these problems.

Further, the problems associated with distribution and delivery of OTC drugs to remote areas can also be solved by digitisation. The doorstep delivery models adapted by pharmacies in urban areas can be customised to suit the rural needs by employing services of the Indian Post Office. This digitisation also provides an added benefit of tracking and moderation of the consumption of these drugs. However, access to the internet and illiteracy will still pose a challenge in this endeavour.

In conclusion, it is only through rationalisation and institutional regulation that any systematic change to a crisis as big as a medical crisis can be tackled. Such regulation has to be comprehensive and cover related topics such as rampant commercial advertising and promotion of OTC medicines. The urgency of instituting these reforms has been justified by the surprise with which the pandemic had caught the nation.

Bombay High CourtOTC drugsSatya Muleyself-medication
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